Acceleration in Clinical Development! Leads Biolabs' LBL-034 Dosed First Patient in Phase Ⅱ Trial

NANJING, China, Aug. 25, 2025 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) today announced the first patient has been successfully dosed in the Phase Ⅱ trial of LBL-034 (GPRC5D/CD3 BsAb) following strong Phase Ⅰ data. This milestone endows LBL-034 with the potential to become the first domestic T-cell engager (TCE) therapy targeting GPRC5D.

Innovative Design with Best-in-Class Potential

LBL-034 is a GPRC5D/CD3 bispecific T-cell engager with a uniquely designed 2:1 format. By optimizing anti-CD3 affinity and steric hindrance, LBL-034 effectively redirects and activates T cells to target GPRC5D+ cancer cells, being less prone to inducing nonspecific T-cell activation. This dual advantage—robust antitumor efficacy combined with favorable safety—positions LBL-034 as a best-in-class candidate.

Outstanding Phase Ⅰ Data with Initial Evidence of CAR-T-Like Efficacy

LBL-034 has demonstrated strong efficacy signal and favorable safety profile among over 50 enrolled patients at dose levels up to 1200 μg/kg in its open-label, multi-center, dose-escalation/expansion phase Ⅰ trial for the treatment of relapsed/refractory multiple myeloma (MM). At higher doses, LBL-034 showed a robust objective response rate (ORR) similar to CAR-T treatment. Notably, promising efficacy was also observed in the subgroup of patients with difficult-to-treat extramedullary (EMD) plasmacytomas. Furthermore, the minimal residual disease (MRD) negativity rate was also significantly higher than with current standard of care. The detailed results of this study, including efficacy, safety, PK/PD, biomarker, and exposure-response analyses, will be presented at the 2025 American Society of Hematology Annual Meeting.

Phase Ⅱ Trial Initiated

The Phase Ⅱ trial of LBL-034 is a multi-center, single-arm, multi-cohort clinical trial led by Professor Lu Jin of Peking University People's Hospital, with participation from over 20 hospitals across China. The trial aims to evaluate the efficacy and safety of LBL-034 in patients with various relapsed/refractory plasma cell neoplasms.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "The successful dosing of the first Phase Ⅱ patient marks a critical step in our TCE pipeline and validates our unique molecular design. We will continue advancing clinical development with high standards to deliver China's first GPRC5D-targeted TCE therapy, offering patients safer and more effective options."

Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs, added, "LBL-034's exceptional Phase Ⅰ data and smooth Phase Ⅱ initiation underscore the core advantage of our Leadsbody™ platform—conditional activation. This success bolsters confidence in our broader pipeline and accelerates breakthroughs in TCE therapies for solid tumors, hematologic malignancies, and autoimmune diseases. We remain committed to driving innovation and delivering transformative treatments globally."

About LBL-034

LBL-034 is a bispecific T-cell engager targeting both GPRC5D and CD3 developed using Leads Biolabs' proprietary LeadsBody™ platform. LBL-034 is designed with a 2:1 format, with two binding sites targeting GPRC5D and one targeting CD3. This design enables LBL-034 to effectively redirect and activate T cells to target GPRC5D+ cancer cells, being less prone to inducing T cell exhaustion and cell death and minimizing the risk of cytokine release syndrome and immunotoxicity.

LBL-034 has exhibited promising efficacy signals in our preclinical studies. According to Frost & Sullivan, as of November 2024, LBL-034 is the second most clinically advanced GPRC5D-targeted CD3 T-cell engager globally and the first in China in terms of clinical progress, and is expected to become the first domestic TCE therapy targeting GPRC5D. LBL-034 obtained the orphan drug designation from the FDA for the treatment of MM in October 2024.

About Leads Biolabs

Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address underserved medical needs in oncology, autoimmune, and other severe diseases both in China and globally.

We are a front-runner in next-generation immuno-oncology treatments with a differentiated pipeline of 14 innovative drug candidates, including six clinical-stage drug candidates, of which four lead products are among the top-tier clinically advanced candidates globally.

We adopt a science-driven R&D approach and have successfully established comprehensive R&D capabilities spanning antibody discovery and engineering, in vivo and in vitro efficacy evaluation, as well as druggability assessment. We have also developed multiple proprietary technology platforms, including LeadsBody™ platform (a CD3 T-cell engager platform), X-body™ platform (a 4-1BB engager platform) , Linker-payload (ADC platform), which serve as the cornerstone for our continued innovation and have been validated by the clinical outcomes of our bispecific antibody portfolios.

We have established integrated capabilities across early discovery, translational medicine, clinical development, CMC and business development. The innovative nature and competitive strengths of our drug candidates, coupled with our global perspectives, proactive strategy, and efficient clinical validation, have made us an attractive partner for leading industry players and venture capitals. For more information, please visit https://en.leadsbiolabs.com/

SOURCE Leads Biolabs